Some of the tablets might be the wrong strength (Image: nortonrsx via Getty Images)
People taking a widely-used blood pressure medication have been warned to carry out a crucial check after an error was discovered that has put some patients at risk. A packaging blunder involving ramipril means some individuals may have been dispensed 10mg capsules in a box labelled 2.5mg.
Approximately 35million prescriptions for ramipril are issued across pharmacies in England every year. While only a single batch of the medication is affected, all users are strongly advised to verify the details on their packaging and take immediate action if they have been supplied with the affected batch. Medication safety specialists have issued clear guidance on what to look for on the packaging — and what steps to take if you have consumed the affected product.
Ramipril tablets (Image: MHRA)
The Medicines and Healthcare products Regulatory Agency has also outlined the symptoms to watch out for and when to seek medical attention. It said: “Crescent Pharma Limited is recalling one batch of ramipril 2.5mg capsules as a precautionary measure due to a packaging error which may mean some cartons contain blister strips of a higher dose, specifically ramipril 10mg.
“This follows a complaint which identified that, inside a sealed carton of Crescent Pharma Limited Ramipril 2.5mg capsules, two blister strips of ramipril 10mg capsules were found by a healthcare professional. Both product batches were manufactured at the same site, and the error appears to have occurred during packaging of the cartons.” Ramipril is a medication prescribed for the treatment of hypertension (high blood pressure), kidney disease and heart failure.
Dr Alison Cave, MHRA Chief Safety Officer, said: “If you take Crescent Pharma Limited Ramipril 2.5mg capsules, check the packaging for batch number GR155023. The batch number and expiry date information can be found on the outer carton. If you have received this batch, check that the medication strength on the carton matches the blister strips inside.
“If the 2.5mg carton of Crescent Pharma Limited Ramipril contains blister strips that are labelled as Ramipril 10mg capsules, do not to take the medicine and contact your dispensing pharmacy. If the carton contains blister strips that are correctly labelled as Crescent Pharma Limited Ramipril 2.5mg capsules, you do not need to take further action and should continue to take your medicine as usual.
“If you have an affected pack or previously received this batch and you believe you have taken any ramipril 10mg capsules that were included in error and are currently experiencing any side effects, please seek medical advice.” She then went on to outline the symptoms that patients should be vigilant about.
She said: “Signs and symptoms may include feeling lightheaded, fainting or being fatigued, or altered kidney function and may be more serious for vulnerable patients. Any possible impact of taking a higher dose of ramipril should be assessed by a healthcare professional to determine whether any examination or tests are needed.
“If you have this batch of medicine, please take the leaflet that came with your medicine and any remaining tablets with you to your pharmacy or GP practice. Any suspected side effects should also be reported via the MHRA Yellow Card scheme.”
Ramipril 5mg Capsule – Batch GR164094 incorrect blister strip (Image: MHRA)
The MHRA has instructed pharmacies and healthcare professionals to cease supplying the affected batch and return all remaining stock to their suppliers. This marks the second ramipril recall in recent weeks.
In April, the MHRA recalled a different batch of the medication, also produced by Crescent Pharma Limited, following another packaging error. On that occasion, a sealed carton of ramipril 10mg capsules was discovered to contain a 5mg blister pack.
It stated at the time: “Crescent Pharma Limited is recalling one batch of Ramipril 10mg Capsules as a precautionary measure due to a potential error at the manufacturing site. Crescent Pharma Limited has received one complaint to date, where it has been identified that, inside a sealed carton of Ramipril 10 mg Capsules Batch No.: GR174091, one blister pack of Ramipril 5 mg Capsules Batch No.: GR164094 was found.
“Both product batches were manufactured at the same manufacturing site and the error appears to have occurred during secondary packaging of the cartons of Batch GR174091. Please note this is a Class 2 Patient, Pharmacy and Wholesaler level recall.”
In announcing the recall, it confirmed all packs from the affected batch were being withdrawn as a precautionary measure. It added: “If you were prescribed Ramipril 10 mg Capsules and have received the impacted product batch (Batch Number GR174091) please check that the carton contains the correct medication. The batch number and expiry date information can be found on outer carton.
“If the carton contains blister strips that are labelled and contain Ramipril 5 mg capsule, contact your dispensing pharmacy in the first instance. If the carton contains blister strips that are labelled and contain Ramipril 10 mg Capsules, you do not need to take further action.
“If you are unsure or have any questions, please seek advice from your pharmacy or other healthcare professionals responsible for your care. Please take the leaflet that came with your medicine and any remaining capsules with you to your pharmacy or GP practice.” In that case, patients were advised that any potential effect of a lower dose of ramipril was expected to be gradual rather than immediate or life-threatening. Anyone who experienced an adverse reaction or had concerns about their medication was urged to seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
This story originally appeared on Express.co.uk
